贝派度酸片
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港股异动 石药集团(01093)尾盘涨近3% 贝派度酸片临床申请获受理 入局全新“非他汀类”降脂药
Jin Rong Jie· 2025-12-17 09:15
公开资料显示,贝派度酸此前已于2020年在美国FDA首次批准上市。市场机构预计贝派度酸片可能会占 领多达四分之一的胆固醇药物市场,并有望达到20亿至30亿美元的峰值销售额。值得一提的是,贝派度 酸片原研药及仿制药均未尚未在国内上市。截至目前为止,国内已有甘李药业山东有限公司、江西施美 药业、合肥立方制药、石药集团欧意药业4家药企申报的贝派度酸片临床申请均获受理,首仿之争已拉 开帷幕。 本文源自:智通财经网 智通财经获悉,石药集团(01093)尾盘涨近3%,截至发稿,涨2.04%,报7.51港元,成交额4.08亿港元。 消息面上,12月15日,据中国国家药品审评中心(CDE)官网最新显示,石药集团旗下全资子公司石药集 团欧意药业有限公司按化药注册分类3类申报的贝派度酸片临床申请获受理。据悉,贝派度酸是一种三 磷酸腺苷-柠檬酸裂解酶抑制剂,主要用于降低低密度脂蛋白胆固醇(LDL-C),适用于无法接受他汀类治 疗的成年患者,能够减少心肌梗死和冠状动脉血运重建的风险。 ...
港股异动 | 石药集团(01093)尾盘涨近3% 贝派度酸片临床申请获受理 入局全新“非他汀类”降脂药
智通财经网· 2025-12-17 08:12
公开资料显示,贝派度酸此前已于2020年在美国FDA首次批准上市。市场机构预计贝派度酸片可能会占 领多达四分之一的胆固醇药物市场,并有望达到20亿至30亿美元的峰值销售额。值得一提的是,贝派度 酸片原研药及仿制药均未尚未在国内上市。截至目前为止,国内已有甘李药业山东有限公司、江西施美 药业、合肥立方制药、石药集团欧意药业4家药企申报的贝派度酸片临床申请均获受理,首仿之争已拉 开帷幕。 消息面上,12月15日,据中国国家药品审评中心(CDE)官网最新显示,石药集团旗下全资子公司石药集 团欧意药业有限公司按化药注册分类3类申报的贝派度酸片临床申请获受理。据悉,贝派度酸是一种三 磷酸腺苷-柠檬酸裂解酶抑制剂,主要用于降低低密度脂蛋白胆固醇(LDL-C),适用于无法接受他汀类治 疗的成年患者,能够减少心肌梗死和冠状动脉血运重建的风险。 智通财经APP获悉,石药集团(01093)尾盘涨近3%,截至发稿,涨2.04%,报7.51港元,成交额4.08亿港 元。 ...
石药集团尾盘涨近3% 贝派度酸片临床申请获受理 入局全新“非他汀类”降脂药
Zhi Tong Cai Jing· 2025-12-17 08:09
消息面上,12月15日,据中国国家药品审评中心(CDE)官网最新显示,石药集团旗下全资子公司石药集 团欧意药业有限公司按化药注册分类3类申报的贝派度酸片临床申请获受理。据悉,贝派度酸是一种三 磷酸腺苷-柠檬酸裂解酶抑制剂,主要用于降低低密度脂蛋白胆固醇(LDL-C),适用于无法接受他汀类治 疗的成年患者,能够减少心肌梗死和冠状动脉血运重建的风险。 石药集团(01093)尾盘涨近3%,截至发稿,涨2.04%,报7.51港元,成交额4.08亿港元。 公开资料显示,贝派度酸此前已于2020年在美国FDA首次批准上市。市场机构预计贝派度酸片可能会占 领多达四分之一的胆固醇药物市场,并有望达到20亿至30亿美元的峰值销售额。值得一提的是,贝派度 酸片原研药及仿制药均未尚未在国内上市。截至目前为止,国内已有甘李药业(603087)山东有限公 司、江西施美药业、合肥立方制药(003020)、石药集团欧意药业4家药企申报的贝派度酸片临床申请 均获受理,首仿之争已拉开帷幕。 ...
立方制药丹皮酚原料药获批上市 产品结构进一步丰富
Zheng Quan Ri Bao Wang· 2025-06-30 13:03
Group 1 - The core point of the article is that Hefei Lifan Pharmaceutical has received approval for the production of Danpi Phenol, which enhances its raw material supply capacity and competitiveness in the market [1] - The new production process for Danpi Phenol is environmentally friendly and cost-effective, allowing for capacity expansion while meeting market demand [1] - The approval of Danpi Phenol is part of a series of product approvals this year, including the approval for the raw material of Docusate Sodium, which further enriches the company's product pipeline [1] Group 2 - The company has also received a clinical trial approval for Beipiduo Acid Tablets, marking a significant step in the development of lipid-lowering drugs and establishing a foundation for expansion in the cardiovascular treatment market [2] - Beipiduo Acid Tablets were originally approved in the U.S. in 2020, and Lifan Pharmaceutical is the third company in China to receive clinical approval, providing it with a first-mover advantage in this field [2] - The biopharmaceutical industry is projected to grow significantly, with the market size expected to reach 2.24 trillion yuan by 2025, indicating a competitive landscape where companies with core technologies and innovation capabilities are likely to succeed [2]
立方制药:收到药品临床试验批准通知书
news flash· 2025-04-24 09:31
Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of Beipaidu Acid Tablets, a drug aimed at lowering LDL-C by inhibiting cholesterol synthesis in the liver [1] Group 1: Product Information - Beipaidu Acid Tablets are classified as a Class 3 chemical drug in the registration application [1] - The original drug was approved for market release in the United States in 2020 and has not yet been launched domestically [1] Group 2: Company Position - The company is the third domestic enterprise to receive approval for clinical trials of this drug [1] - The approval of the clinical trial application is not expected to have a significant impact on the company's short-term performance [1]